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CPG Sec. 140.100 Seizure of Books that Constitute Misleading Labeling August 1989

Issued by:
Guidance Issuing Office
Office of Regulatory Affairs


For many years, the agency has recommended the seizure not only of violative articles but also the labeling which causes them to be violative.

Printed material that promotes the use of a product is labeling within the meaning of the Act. In order to be labeling, the printed material must "accompany" the product in any one of several ways which have been well established by the courts. Although all accompanying materials constitute labeling, the extent to which they "accompany" it may be direct or indirect. For example, some printed material may consist of a printed sheet bearing the name of a particular product, stating its intended uses and directions for use, and naming the manufacturer and/or distributor. Some printed material may contain statements about several products, which statements occupy a reasonably small portion of the material, for example, one chapter in a book of twenty chapters. Additionally, this labeling may be printed not on behalf of the manufacturer or distributor of a product but by an unrelated publishing company, and may be sold routinely in book stores as well as in certain locations where its association with a product evidences the fact that it is labeling.

Over the years, courts have condemned and ordered destroyed labeling that was seized along with the product. In three cases, a claimant challenged the court's authority under the Act to seize, condemn and destroy labeling, arguing that these actions are contrary to the free speech protections of the first amendment. The courts have rejected these challenges although one court overturned the seizure of books displayed near a violative article by concluding that the books were not labeling, in that they did not "accompany" the article, rather than by reaching the first amendment issue.

In 1976, the Supreme Court extended certain free speech protections of the first amendment to what the court called "commercial speech" which includes printed material. Such speech consists of proposing or promoting a commercial transaction by, among other things, extolling the benefit of a particular product. Notwithstanding certain free speech protections, labeling including books can be regulated if it is false or misleading.

In addition to establishing certain judicial protections for commercial speech, the courts have established that speech, including commercial speech, should not be subject to a prior restraint. A prior restraint exists where the dissemination of certain speech is restricted or prohibited before its violative nature has been judicially determined. The authority provided by section 304 of the Act to seize without a prior hearing may be argued to be an unconstitutional prior restraint.


Where labeling other than books renders a product to be violative, and the labeling is closely associated with the product in question *(e.g. brand name, proximity at point of sale)* the agency will continue to recommend seizure of both the product and the labeling.

Where labeling is in the form of a book and the agency believes that the use of the book to promote the product creates a significant consumer deception, the agency will consider filing a complaint for forfeiture *against the product and an injunction to halt, after a hearing, the misuse of the book.*

*Material between asterisks is new or revised*

Issued: 12/1/82

Revised: 8/31/89

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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